Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

NCT07400757 | Recruiting

• 1 other identifier: 2025-08-018A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether statin therapy and vitamin D supplementation can modify disease activity in patients with active thyroid eye disease. The study will also evaluate the safety of these treatments. The main questions it aims to answer are:

• Does statin therapy change disease activity, as measured by changes in the Clinical Activity Score (CAS) and proptosis?
• Does vitamin D supplementation change disease activity in patients with active thyroid eye disease?
• Does combined treatment with statin and vitamin D produce different effects compared with either treatment alone or standard care?
• What adverse events occur during treatment? Researchers will compare four groups: standard care alone, statin therapy plus standard care, vitamin D supplementation plus standard care, and combined statin and vitamin D therapy plus standard care. Participants will:
• Be randomly assigned to one of four treatment groups
• Receive the assigned treatment for 24 weeks
• Attend clinic visits for clinical assessments and blood tests at baseline and at 24 weeks
• Be followed through medical record review for up to three years after completion of the intervention

Conditions

Thyroid Eye Disease, TED; Graves Ophthalmopathy

Keywords

Thyroid Eye Disease; Graves Ophthalmopathy; Statin; Vitamin D; Atorvastatin; Autoimmune Disease; Inflammation; Randomized Controlled Trial; Factorial Design; Clinical Activity Score

Outcome Measures

Primary Outcomes (4)

• Change in Clinical Activity Score (CAS)

  The Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)

  Baseline to 24 weeks

• Change in Thyroid Eye Disease Activity (Responder Analysis)

  Proportion of participants achieving a ≥2-point change in the Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)

  Baseline to 24 weeks

• Change in Proptosis

  Change in proptosis measured by Hertel exophthalmometry

  Baseline to 24 weeks

• Change in Thyroid-Stimulating Immunoglobulin (TSI)

  Change in serum thyroid-stimulating immunoglobulin (TSI) levels

  Baseline to 24 weeks

Secondary Outcomes (4)

• Change in Thyroid Function

  Baseline to 24 weeks

• Change in Lipid Profile

  Baseline to 24 weeks

• Change in Blood Glucose

  Baseline to 24 weeks

• Concomitant Medication Use

  Baseline to 24 weeks

Study Arms (4)

Standard Care

NO INTERVENTION

Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks.

Statin

EXPERIMENTAL

Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks.

Drug: Atorvastatin (Lipitor)

Vitamin D

EXPERIMENTAL

Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.

Dietary Supplement: Vitamin D

Statin plus Vitamin D

EXPERIMENTAL

Participants receive standard care plus oral atorvastatin 20 mg once daily and oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.

Drug: Atorvastatin (Lipitor); Dietary Supplement: Vitamin D

Interventions

Atorvastatin (Lipitor) DRUG

Oral atorvastatin 20 mg administered once daily for 24 weeks.

Statin; Statin plus Vitamin D

Vitamin D DIETARY_SUPPLEMENT

Oral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks.

Statin plus Vitamin D; Vitamin D

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 years or older
• Diagnosis of active thyroid eye disease with a Clinical Activity Score (CAS) of 3 or higher
• Low-density lipoprotein cholesterol (LDL-C) level of 100 mg/dL or higher

You may not qualify if:

• Prior orbital radiotherapy or orbital surgery for thyroid eye disease
• Use of statins or high-dose vitamin D supplementation (greater than 400 IU per day) within 3 months prior to enrollment
• Pregnancy
• Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 11217, Taiwan

RECRUITING

Related Publications (3)

• Cardo C, Bernardo Santos R, Pinotti Pedro Miklos AB, Barbosa Jaconis S, Romaldini JH, Villagelin D. The relationship between cholesterol levels and thyroid eye disease. Eur Thyroid J. 2025 Feb 3;14(1):e240133. doi: 10.1530/ETJ-24-0133. Print 2025 Feb 1.

  PMID: 39819487 BACKGROUND

• Chou YT, Lai CC, Li CY, Shen WC, Huang YT, Wu YL, Lin YH, Yang DC, Yang YC. Statin Use and the Risk of Graves' Orbitopathy: A Nationwide Population-Based Cohort Study. Thyroid. 2025 Feb;35(2):199-207. doi: 10.1089/thy.2024.0536. Epub 2025 Jan 13.

  PMID: 39804287 BACKGROUND

• Wang CM, Chen YJ, Yang BC, Yang JW, Wang W, Zeng Y, Jiang J. Supplementation with active vitamin D3 ameliorates experimental autoimmune thyroiditis in mice by modulating the differentiation and functionality of intrathyroidal T-cell subsets. Front Immunol. 2025 Jan 30;16:1528707. doi: 10.3389/fimmu.2025.1528707. eCollection 2025.

  PMID: 39949783 BACKGROUND

MeSH Terms

Conditions

Graves Ophthalmopathy; Autoimmune Diseases; Inflammation

Interventions

Atorvastatin; Vitamin D

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chin-Sung Kuo, MD, PhD

  Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Sung Kuo, MD, PhD

CONTACT

886-2-28757513; cskuo@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Neither the participants nor the investigators are blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study uses a 2×2 factorial, parallel-group design to evaluate the independent and combined effects of statin therapy and vitamin D supplementation. Participants are randomly assigned to one of four groups: standard care alone, statin plus standard care, vitamin D plus standard care, or combined statin and vitamin D plus standard care.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 15, 2032
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)